acute and long-term antidepressant treatment success in adolescents with anxiety (atlas-a)

Conditions: Anxiety; Depressive Symptoms

Summary: acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

to identify predictors of the magnitude and trajectory of response to flexibly-dosed duloxetine and escitalopram response in adolescents with anxiety, including those with depressive symptoms. and also to examine long-term predictors of sustained response and relapse in adolescents. to examine predictors of developing depressive disorders in anxious adolescents.

Eligibility criteria:
inclusion criteria: * written, informed assent and consent. * patients, parent/guardian/lar must be fluent in the english. * 12 to 17 years of age, inclusive, at screening. * patients must meet dsm-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the mini-kid. * caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product. * no clinically significant abnormalities on physical examination. * negative pregnancy test at screening in females. * negative urine drug screen at screening. * sexually active patients must practice a reliable method of contraception (section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted: 1. surgical sterilization 2. oral contraceptives (e.g. estrogren-progestin combination or progestin) 3. transdermally-delivered contraceptives (e.g., ortho-evra), depot injections (e.g., depo-provera) 4. vaginal contraceptive ring (e.g., nuvaring), contraceptive implants (e.g., implanon, norplant ii/jadelle) 5. an intrauterine device 6. diaphragm plus condom. exclusion criteria: * dsm-512 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment. * a history of intellectual disability. * suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at visit 1 (screening) or visit 2 (baseline), as judged by the investigator. * allergy, intolerance, non-response or hypersensitivity to escitalopram or duloxetine. * subjects taking other medications that require a taper or washout of more than 5 days. * patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before visit 2 (baseline), or who plan to initiate/change said therapies during the course of the study will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline. * a clinically-significant medical illness. * qtc \>450 in males / \>460 in females (prolonged qtc based on american heart association recommendations for standardization and interpretation of the ekg81 * alcohol or substance use disorder within the past 6 months (nicotine use is permitted). * positive urine pregnancy test/pregnancy or breast feeding. * a positive urine drug screen. * patients who are unable to swallow capsules.